FDA 510(k) Application Details - K072741

Device Classification Name

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510(K) Number K072741
Device Name PRE-VA VAGINAL LUBRICANT
Applicant INGFERTILITY, LLC
17206 S. SPANGLE CREEK RD.
VALLEYFORD, WA 99036 US
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Contact DENNIS CLIFTON
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Regulation Number

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Classification Product Code PEB
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Date Received 09/27/2007
Decision Date 07/16/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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